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Senior Regulatory Affairs Specialist

Job description

Senior Regulatory Affairs Specialist

 

Responsibilities

  • Work with the national and international regulatory affairs teams to provide support in change management for products and also addressing potential issues and questions for regulatory bodies.
  • Prepare regulatory submissions and CE Mark Technical files for NPD and product change projects and activities.
  • Addressing MDR and remediation issues and applying all necessary actions across the business portfolios.
  • Review documentation for products live in the market in relation to any changes and also interacting with the FDA directly and indirectly plus reviewing with management any significant issues.
  • Maintain and update insight database.
  • Ensure focus of business and departments on compliance to global regulations and international standards.

 

Requirements

  • Level 8 degree with 4 years or more experience in QA and RA within a medical device or similarly regulated environment.
  • Working knowledge of Medical Device QMS under 21 CFR 820, ISO13483/MDD and MDR
  • Would be beneficial to have ISO, GHTF and ICH standards experience.
  • Preferable to have experience in medical devices (510(k), PMA), pharmaceuticals, or combination products (drug/biologic-device).

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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